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Innate Immune Responses in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT ID: NCT00826163

Last Updated: 2013-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

Brief Summary

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We hypothesize that ongoing and more severe airway inflammation in COPD may result from the impairment in activation of innate immune response

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stable COPD

Postbronchodilator FEV1\> or = 50% predicted

Group Type ACTIVE_COMPARATOR

Budesonide

Intervention Type DRUG

Inhaled budesonide 400 mcg twice a day for 2 weeks

Asthma

Postbronchodilator FEV1 \> or = 50% predicted

Group Type SHAM_COMPARATOR

Budesonide

Intervention Type DRUG

Inhaled budesonide 400 mcg twice a day for 2 weeks

Interventions

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Budesonide

Inhaled budesonide 400 mcg twice a day for 2 weeks

Intervention Type DRUG

Other Intervention Names

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Rhinocort

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of COPD or asthma
* a ratio of prebronchodilator FEV1 to forced vital capacity (FVC) equal to or less than 0.70
* postbronchodilator FEV1 \> or = 50% predicted

Exclusion Criteria

* Exacerbation
* systemic corticosteroids
* DM, HIV and autoimmune disease
* immunosuppressive therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Development Agency, Thailand

OTHER_GOV

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Kittipong Maneechotesuwan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kittipong Maneechotesuwan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Kittipong Maneechotesuwan

Bangkoknoi, BKK, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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BT-B-01-MG-14-5114

Identifier Type: -

Identifier Source: org_study_id